Trial Outcomes & Findings for Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031) (NCT NCT00729183)
NCT ID: NCT00729183
Last Updated: 2018-08-27
Results Overview
aBMD (g/cm\^2) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and mean BMD measurements from at least 3 evaluable lumbar spine vertebrae (L1-L4) were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal Analysis of Covariates (ANCOVA) model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.
COMPLETED
PHASE3
214 participants
Baseline, 12 months
2018-08-27
Participant Flow
214 participants who met inclusion criteria were randomized into either the Odanacatib 50 mg arm (N=109) or the Placebo arm (N=105).
Participant milestones
| Measure |
Odanacatib 50 mg
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
105
|
|
Overall Study
COMPLETED
|
84
|
90
|
|
Overall Study
NOT COMPLETED
|
25
|
15
|
Reasons for withdrawal
| Measure |
Odanacatib 50 mg
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
Baseline Characteristics
Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)
Baseline characteristics by cohort
| Measure |
Odanacatib 50 mg
n=109 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=105 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: Full-Analysis-Set (FAS) population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 12 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline (BL) data.
aBMD (g/cm\^2) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and mean BMD measurements from at least 3 evaluable lumbar spine vertebrae (L1-L4) were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal Analysis of Covariates (ANCOVA) model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.
Outcome measures
| Measure |
Odanacatib 50 mg
n=96 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=97 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD)
|
3.63 percent change
Interval 3.04 to 4.21
|
0.14 percent change
Interval -0.45 to 0.72
|
PRIMARY outcome
Timeframe: Up to ~14 days post study end (up to ~24 months)Population: All-Participants-as-Treated (APaT) population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.
Outcome measures
| Measure |
Odanacatib 50 mg
n=109 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=105 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percentage of Participants That Experienced an Adverse Event (AE)
|
82.6 percentage of participants
|
84.8 percentage of participants
|
PRIMARY outcome
Timeframe: Up to ~14 days post study end (up to ~24 months)Population: APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that discontinued study treatment (different from discontinuation of the study) due to an AE was reported for each treatment arm.
Outcome measures
| Measure |
Odanacatib 50 mg
n=109 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=105 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percentage of Participants That Discontinued Study Treatment Due to an AE
|
10.1 percentage of participants
|
5.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 24 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline data.
aBMD (g/cm\^2) was measured by DXA at the lumbar spine and mean BMD measurements from at least 3 evaluable vertebrae from L1 through L4 were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.
Outcome measures
| Measure |
Odanacatib 50 mg
n=83 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=90 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline to Month 24 in Lumbar Spine aBMD
|
5.02 percent change
Interval 4.28 to 5.76
|
-0.38 percent change
Interval -1.09 to 0.34
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total hip aBMD endpoint data subsequent to at least one dose of study treatment, and having total hip aBMD baseline data.
aBMD (g/cm\^2) data was measured by DXA at the total hip. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total hip was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.
Outcome measures
| Measure |
Odanacatib 50 mg
n=96 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=97 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Total Hip aBMD
Month 12 (n=96, n=97)
|
1.41 percent change
Interval 0.92 to 1.89
|
-0.16 percent change
Interval -0.64 to 0.32
|
|
Percent Change From Baseline in Total Hip aBMD
Month 24 (n=82, n=90)
|
2.43 percent change
Interval 1.76 to 3.1
|
-0.89 percent change
Interval -1.55 to -0.24
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization femoral neck aBMD endpoint data subsequent to at least one dose of study treatment, and having femoral neck aBMD baseline data.
aBMD (g/cm\^2) data was measured by DXA at the femoral neck (hip). All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the femoral neck was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.
Outcome measures
| Measure |
Odanacatib 50 mg
n=96 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=97 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck aBMD
Month 12 (n=96, n=97)
|
1.03 percent change
Interval 0.41 to 1.65
|
-0.45 percent change
Interval -1.07 to 0.17
|
|
Percent Change From Baseline in Femoral Neck aBMD
Month 24 (n=82, n=90)
|
2.47 percent change
Interval 1.67 to 3.28
|
-1.33 percent change
Interval -2.11 to -0.56
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization hip trochanter aBMD endpoint data subsequent to at least one dose of study treatment, and having hip trochanter aBMD baseline data.
aBMD (g/cm\^2) data was measured by DXA at the hip trochanter. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the hip trochanter was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.
Outcome measures
| Measure |
Odanacatib 50 mg
n=96 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=97 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Hip Trochanter aBMD
Month 12 (n=96, n=97)
|
2.37 percent change
Interval 1.59 to 3.15
|
0.18 percent change
Interval -0.6 to 0.95
|
|
Percent Change From Baseline in Hip Trochanter aBMD
Month 24 (n=82, n=90)
|
4.75 percent change
Interval 3.75 to 5.76
|
-0.73 percent change
Interval -1.71 to 0.25
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total radius aBMD endpoint data subsequent to at least one dose of study treatment, and having total radius aBMD baseline data.
aBMD (g/cm\^2) data was measured by DXA at the total radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.
Outcome measures
| Measure |
Odanacatib 50 mg
n=96 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=96 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Total Radius aBMD
Month 12 (n=96, n=96)
|
0.01 percent change
Interval -0.44 to 0.47
|
-0.70 percent change
Interval -1.15 to -0.24
|
|
Percent Change From Baseline in Total Radius aBMD
Month 24 (n=82, n=90)
|
-0.19 percent change
Interval -0.71 to 0.34
|
-1.89 percent change
Interval -2.4 to -1.38
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization ultradistal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having ultradistal radius aBMD baseline data.
aBMD (g/cm\^2) data was measured by DXA at the ultradistal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the ultradistal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.
Outcome measures
| Measure |
Odanacatib 50 mg
n=96 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=96 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Ultradistal Radius aBMD
Month 12 (n=96, n=96)
|
0.98 percent change
Interval 0.25 to 1.7
|
-0.73 percent change
Interval -1.46 to -0.01
|
|
Percent Change From Baseline in Ultradistal Radius aBMD
Month 24 (n=82, n=90)
|
1.25 percent change
Interval 0.48 to 2.03
|
-1.45 percent change
Interval -2.2 to -0.69
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization distal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having distal radius aBMD baseline data.
aBMD (g/cm\^2) data was measured by DXA at the one-third distal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the distal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.
Outcome measures
| Measure |
Odanacatib 50 mg
n=96 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=96 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Distal Radius aBMD
Month 12 (n=96, n=96)
|
-0.21 percent change
Interval -0.77 to 0.35
|
-0.37 percent change
Interval -0.92 to 0.19
|
|
Percent Change From Baseline in Distal Radius aBMD
Month 24 (n=82, n=90)
|
-0.57 percent change
Interval -1.25 to 0.12
|
-1.79 percent change
Interval -2.46 to -1.12
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L1) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L1) baseline data.
Trabecular vBMD at the lumbar spine (L1) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L1) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.
Outcome measures
| Measure |
Odanacatib 50 mg
n=82 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=86 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)
Month 12 (n=82, n=86)
|
6.58 percent change
Interval 5.17 to 7.99
|
-1.43 percent change
Interval -2.81 to -0.04
|
|
Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)
Month 24 (n=72, n=79)
|
6.44 percent change
Interval 4.64 to 8.24
|
-5.02 percent change
Interval -6.76 to -3.28
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L2) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L2) baseline data.
Trabecular vBMD at the lumbar spine (L2) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L2) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.
Outcome measures
| Measure |
Odanacatib 50 mg
n=84 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=86 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)
Month 12 (n=84, n=86)
|
5.67 percent change
Interval 4.32 to 7.02
|
-0.00 percent change
Interval -1.34 to 1.34
|
|
Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)
Month 24 (n=73, n=79)
|
5.97 percent change
Interval 4.25 to 7.68
|
-3.41 percent change
Interval -5.08 to -1.74
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: Per-Protocol (PP) population: All participants receiving at least one dose of study treatment and with available s-CTx data, excluding participants with important deviations from the protocol that may have substantially affected the results.
s-CTx is a biochemical marker index of bone resorption. s-CTx was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. S-CTx was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.
Outcome measures
| Measure |
Odanacatib 50 mg
n=89 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=87 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level
Month 12 (n=89, n=87)
|
-53.33 percent change
Interval -57.62 to -48.61
|
0.70 percent change
Interval -8.7 to 11.07
|
|
Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level
Month 24 (n=74, n=78)
|
-42.56 percent change
Interval -50.27 to -33.65
|
3.03 percent change
Interval -10.57 to 18.69
|
SECONDARY outcome
Timeframe: Baseline, 12 months, 24 monthsPopulation: PP population: All participants receiving at least one dose of study treatment and with available s-P1NP data, excluding participants with important deviations from the protocol that may have substantially affected the results.
s-P1NP is a biochemical marker index of bone formation. s-P1NP was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. s-P1NP was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.
Outcome measures
| Measure |
Odanacatib 50 mg
n=90 Participants
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=88 Participants
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level
Month 12 (n=90, n=88)
|
-28.32 percent change
Interval -35.3 to -20.58
|
-2.97 percent change
Interval -12.57 to 7.69
|
|
Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level
Month 24 (n=76, n=80)
|
-11.06 percent change
Interval -20.4 to -0.61
|
-1.99 percent change
Interval -12.32 to 9.56
|
Adverse Events
Odanacatib 50 mg
Placebo
Serious adverse events
| Measure |
Odanacatib 50 mg
n=109 participants at risk
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=105 participants at risk
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Coronary artery disease
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
General disorders
Chest pain
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
General disorders
Pyrexia
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Immune system disorders
Sarcoidosis
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Gastroenteritis
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
1.9%
2/105 • Number of events 2 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.8%
3/109 • Number of events 4 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.8%
2/109 • Number of events 2 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
2/109 • Number of events 2 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/109 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.92%
1/109 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/105 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
Other adverse events
| Measure |
Odanacatib 50 mg
n=109 participants at risk
Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
Placebo
n=105 participants at risk
Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.5%
6/109 • Number of events 6 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
2/109 • Number of events 3 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
5.7%
6/105 • Number of events 6 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Bronchitis
|
1.8%
2/109 • Number of events 2 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
6.7%
7/105 • Number of events 9 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Cystitis
|
4.6%
5/109 • Number of events 6 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
5.7%
6/105 • Number of events 9 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Influenza
|
9.2%
10/109 • Number of events 10 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
5.7%
6/105 • Number of events 6 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
13.8%
15/109 • Number of events 18 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
7.6%
8/105 • Number of events 10 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Urinary tract infection
|
7.3%
8/109 • Number of events 11 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
9.5%
10/105 • Number of events 10 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
2/109 • Number of events 2 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
7.6%
8/105 • Number of events 10 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
18/109 • Number of events 19 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
13.3%
14/105 • Number of events 15 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.0%
12/109 • Number of events 14 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
15.2%
16/105 • Number of events 19 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.5%
6/109 • Number of events 8 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
2.9%
3/105 • Number of events 3 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.5%
6/109 • Number of events 6 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
2.9%
3/105 • Number of events 3 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.6%
5/109 • Number of events 9 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
7.6%
8/105 • Number of events 10 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Headache
|
5.5%
6/109 • Number of events 7 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
0.95%
1/105 • Number of events 1 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
3/109 • Number of events 3 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
8.6%
9/105 • Number of events 10 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.92%
1/109 • Number of events 2 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
5.7%
6/105 • Number of events 6 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.6%
5/109 • Number of events 6 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
8.6%
9/105 • Number of events 12 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
|
Vascular disorders
Hypertension
|
6.4%
7/109 • Number of events 7 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
3.8%
4/105 • Number of events 4 • ~14 days post study end (up to ~24 months)
APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER